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Data / Medical devices / Stents, Drains And Dilators For The Biliary Ducts

Stents, Drains And Dilators For The Biliary Ducts (FGE): 90 FDA-registered makers in 15 countries

90 establishments in 15 countries are registered with the FDA to make Stents, Drains And Dilators For The Biliary Ducts (product code FGE, Class 2, 21 CFR 876.5010). 69 of them have a 510(k) clearance or PMA approval on file and 16 have a recall event. The FDA has issued 478 510(k) clearances under this code, the latest on September 18, 2026, and lists 97 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
FGE
Device class
2
Regulation
876.5010
Medical specialty
Gastroenterology, Urology
Implant
Yes
Life sustaining or supporting
Yes

Makers by country

CountryMakers
United States46
China8
Mexico7
South Korea5
Ireland4
Costa Rica4
Japan3
Germany3
Taiwan2
Israel2
Vietnam2
Malaysia1
Denmark1
Czechia1
Slovakia1

Makers of Stents, Drains And Dilators For The Biliary Ducts

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Boston Scientific CorporationCoventry, RI, United StatesManufacturer, Manufacturer for export23July 3, 2025000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer, Specification developer23July 3, 2025000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer19July 3, 20250110api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Manufacturer for export, Specification developer13July 6, 2012080api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export11May 1, 2018070api.fda.gov
Cook Medical LLCBloomington, IN, United StatesComplaint file establishment, Contract manufacturer10June 14, 2024010api.fda.gov
Cook Ireland LtdLIMERICK Limerick(County), IrelandComplaint file establishment, Manufacturer8June 14, 2024000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesManufacturer8March 18, 20080180api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer, Manufacturer for export7July 3, 2025020api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer6October 21, 2025010api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer6October 21, 2025000api.fda.gov
Angiomed GMBH & Co. Medizintechnik KGKARLSRUHE Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer5August 30, 2013010api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer4October 4, 2017000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer4April 22, 2005000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer4April 24, 2026000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer4April 24, 2026000api.fda.gov
Taewoong Medical Co., LtdGimpo-Si Gyeonggi, South KoreaManufacturer4December 29, 2025000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer4March 1, 2002000api.fda.gov
Abbott VascularTemecula, CA, United StatesComplaint file establishment, Manufacturer3August 18, 2008020api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer3March 28, 1991010api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer3January 24, 2008000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer3March 28, 1991000api.fda.gov
Bioteque Corporation Yilan Science Park FactoryYilan City, TaiwanComplaint file establishment, Manufacturer3December 22, 2025000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer3August 22, 2014030api.fda.gov
Cardinal Health Mexico 244 S de RL de CVCiudad Juarez Chihuahua, MexicoManufacturer3February 6, 2008000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer3March 8, 2018000api.fda.gov
M.i.tech Co., Ltd.Jeonju Jeonbuk, South KoreaManufacturer3May 11, 2021000api.fda.gov
M.I.Tech Co LtdPyeongtaek Gyeonggi, South KoreaManufacturer3May 11, 2021000api.fda.gov
M.I.Tech Co., Ltd.Seoul, South KoreaSpecification developer3May 11, 2021000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Specification developer3March 14, 2019030api.fda.gov
W. L. Gore & Associates, Inc.Elkton, MD, United StatesManufacturer3May 8, 2017020api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer2August 18, 2008000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer2March 30, 2017000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer2March 30, 2017000api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaSpecification developer2December 20, 2002000api.fda.gov
Bioteque Corporation I-Lan Factory IISu-Ao Cheng Yilan, TaiwanManufacturer2April 13, 2022000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer2December 20, 2002000api.fda.gov
Endogi Medical, Ltd.Nazareth Northern, IsraelManufacturer2September 27, 2023000api.fda.gov
Q3 Medical Usa, LLCCharlotte, NC, United StatesComplaint file establishment, Manufacturer2July 27, 2026000api.fda.gov
Sewoon Medical Co., Ltd.Cheonan-si Chungnam, South KoreaManufacturer2June 16, 2014000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer2October 13, 20170100api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer, Manufacturer1May 23, 1996000api.fda.gov
Asahi Intecc Co., Ltd.SETO Aichi, JapanManufacturer, Specification developer1December 17, 2024000api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoManufacturer1January 18, 1991000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesComplaint file establishment, Specification developer1January 18, 1991000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex, Incorporated)Chelmsford, MA, United StatesManufacturer1January 18, 1991000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer1February 13, 1991000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer1October 12, 2016060api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer1November 7, 1996000api.fda.gov
Boston Scientific Medical Device (Malaysia) SDN BHDTaman Perindustrian Batu Kawan Pulau Pinang, MalaysiaManufacturer1August 22, 2014000api.fda.gov
Canyon Medical Inc.Nanjing Jiangsu, ChinaManufacturer1September 18, 2026000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1November 24, 1992000api.fda.gov
Dongguan TT Medical, Inc.Dongguan Guangdong, ChinaManufacturer1March 9, 2023000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer1February 13, 1991000api.fda.gov
Endofix Medical TechnologiesPlainville, MA, United StatesSpecification developer1August 20, 2025000api.fda.gov
Gie MedicalBrooklyn Park, MN, United StatesManufacturer1March 13, 2026000api.fda.gov
Gyrus Acmi, Inc.Westborough, MA, United StatesSpecification developer1March 8, 2018000api.fda.gov
Hobbs Medical, Inc.Stafford Springs, CT, United StatesManufacturer1March 22, 1984010api.fda.gov
Hangzhou AGS MedTech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer, Repackager or relabeler1June 24, 2026000api.fda.gov
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.Changzhou Jiangsu, ChinaManufacturer1February 15, 2024000api.fda.gov
Leo Medical Co., Ltd.Changzhou Jiangsu, ChinaManufacturer1December 20, 2024000api.fda.gov
Lucas Medical, Inc.Orange, CA, United StatesManufacturer1May 10, 1996000api.fda.gov
Medi-Globe GMBHAchenmuhle, Germany Bavaria, GermanyComplaint file establishment, Manufacturer, Specification developer1April 16, 2026000api.fda.gov
Medinol Ltd.TEL-AVIV Tel Aviv, IsraelSpecification developer1January 9, 2009000api.fda.gov
Mermaid Medical A/SStenloese Hovedstaden, DenmarkManufacturer, Repackager or relabeler1December 22, 2025000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1January 18, 1991000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer1June 17, 2003000api.fda.gov
Uresil, LLCSkokie, IL, United StatesManufacturer1July 13, 1993000api.fda.gov
Zhejiang Chuangxiang Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer1March 6, 2026000api.fda.gov
Admedes Inc.Livermore, CA, United StatesContract manufacturer0000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Asahi Intecc Hanoi Co., Ltd.Hanoi Ha Noi, VietnamContract manufacturer0000api.fda.gov
Burpee Materials Technology, LLCEatontown, NJ, United StatesContract manufacturer0000api.fda.gov
Biomerics CartagoCartago, Costa RicaContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Cook IncorporatedEllettsville, IN, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Harmac Medical Products, Inc.Buffalo, NY, United StatesContract manufacturer0000api.fda.gov
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Lake Region Medical LimitedNEW ROSS Wexford, IrelandContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesSpecification developer0000api.fda.gov
Medi-Globe SroHRANICE Olomouc, CzechiaContract manufacturer0000api.fda.gov
Merit Maquiladora Mexico, S. DE R.L. DE C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Norman Noble, Inc.Highland Heights, OH, United StatesContract manufacturer0000api.fda.gov
Nitinol Devices & Components Costa Rica, S. R. L.El Coyol Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Olympus Vietnam Co. Ltd.Dong Nai City, VietnamManufacturer0000api.fda.gov
Q3 Medical Germany GMBHWinsen (Luhe) Lower Saxony, GermanyContract manufacturer0000api.fda.gov
Quasar Medical Tecate, S.A. de C.VTecate Baja California, MexicoContract manufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Sage Product Development, Inc.Foxborough, MA, United StatesContract manufacturer0000api.fda.gov
Seisa Europe s.r.o.myjava Trenciansky, SlovakiaContract manufacturer0000api.fda.gov

Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.